K233337
- 510(k) number
- K233337
- Device name
- Freespira Breathing System
- Applicant
- Freespira, Inc. WA · US
- Product code
- SEN — Biofeedback For Adjunctive Treatment Of Symptoms Ass
- Decision date
- 2025-04-24
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
Official FDA record: K233337
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.